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R&D Quality Engineer

Job Details
Posted Date:
October 24, 2021

Job ID:

St. Louis , MO

5 years

Job Description
  • Location: St. Louis, MO
  • Type: Contract
  • Job #7452

Technology Partners is currently seeking a talented R&D Quality Engineer (145256). Do you have experience with R&D? Let us help you make your next big career move a reality!

What You Will Be Doing:
You are responsible to assist in the implementation and maintenance of effective Quality Systems in accordance with FDA Quality Systems Regulation, ISO 9001, ISO 13485 and other applicable country specific regulations. Participates and provides guidance to quality improvement teams on tools, techniques and management systems for quality assurance, compliance, and continuous quality improvement. Through effective use of quality tools ensures products (including services) are developed, tested and transferred to manufacturing according to established procedures that will assure that they meet all quality requirements. Contribute in the documentation of quality systems and programs in the areas of training, change management, validation, design controls, CAPA, etc. to ensure compliance with FDA and regulatory requirements. Quality Engineering Support for Design Control Process. Implement project risk management planning as needed. Facilitate and participate in design reviews, develop quality engineering deliverables and assure Design History File (DHF) is updated as necessary. Serve as contact for assigned program(s) and provide coaching / mentoring to project managers and/or project team in regard to the product development process, design control (e.g. risk assessment), etc. Review and provide feedback on product documentation to support the product development process. Serve as a chairperson or committee member for technical or specialty design review(s) during product development or serve as chairperson for change management process. Assists in the development and execution of training programs (e.g. change control, risk analysis, Design Controls, etc.). Develop and/or edit standard operating procedures. Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design quality. Support the Internal Audit Program. Participate in internal audits per schedule, and review the results of all audits to ensure resolution of any noted deviations. Participates in CAPA activities, including investigation, effectiveness, and root cause analysis. Support implementation of corrective actions and preventive measures.

Required Skills & Experience:

  • Requires a minimum of five (5) years experience in a related industry regulated by FDA and/or ISO.
  • Requires demonstrated competence in the selection and use of Quality Engineering tools, techniques, and processes.
  • Must have exposure to and knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, MDSAP, etc.).
  • One or more of the following certifications is desired for this role: Certified Quality Engineering (CQE), Certified Quality Auditor (CQA), Certified Software Quality Engineer (CSQE), Certified Reliability Engineering (CRE), Certified Biomedical Auditor (BCA), or Six Sigma Black Belt.
  • Requires effective written and oral communication skills to interact across all levels of the organization.
  • Must have experience in and knowledge of Microsoft Office Package (Word, Excel, etc.).
  • Microbiology and/or medical technology knowledge/background desired.

If this position sounds like you, WE SHOULD TALK!

We realize our people are our most valuable asset, that is why we offer the following benefits:

  • Health, Dental, and Vision insurance
  • 401(k) retirement plan
  • Long and Short-Term disability
  • Life insurance
  • Direct deposit
  • Referral program

Your better future is ready, and we want to put the right tools in your hands to get you there. Let’s go!

Keywords: R&D, Quality Engineer

Looking for more opportunities with Technology Partners? Check out!

Technology Partners is an Equal Opportunity Employer. Technology Partners does not discriminate on the basis of race, color, religion, sex, national origin, age, disability or any other characteristic protected by applicable state or federal civil rights laws.

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